BURN CREAM- benzalkonium chloride, lidocaine hci cream 
Trifecta Pharmaceuticals USA LLC

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Globe First Aid Burn Cream

Active Ingredient

Lidocaine HCL 0.5%

Purpose

Topical Analgesic

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

Temporary Relief of pain associated with minor cuts, scrapes and burns.

Helps protect against harmful bacteria.

Warnings

For external Use Only

Do not use

Directions

Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Diazolidinyl urea, Edetate disodium, glycerin, methylparaben, Mineral oil, Mono and di glycerides, PEG-100 stearate, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Questions

Call: 1-888-296-9067

Storage Information

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Package Label

R519539 GLOBE FIRST AID BURN CREAM 0.9G 10CT 092623 CDER

Package Label

R519541 GLOBE FIRST AID BURN CREAM 0.9G 25CT 092623 CDER

BURN CREAM 
benzalkonium chloride, lidocaine hci cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-136
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.005 g  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-136-1010 in 1 CARTON10/23/2023
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:69396-136-2525 in 1 CARTON10/23/2023
20.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00310/23/2023
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 10/2023
Document Id: 08a13e35-789e-3322-e063-6294a90a47fa
Set id: 087ac43c-1076-d1e2-e063-6294a90a5859
Version: 2
Effective Time: 20231026
 
Trifecta Pharmaceuticals USA LLC